Supportive Care Intervention-Pancreas (SCI-P)
10 de maio de 2016 atualizado por: Yael Schenker, MD, MAS, University of Pittsburgh
A Pilot Trial of an Embedded Collaborative Model of Supportive Care for Pancreatic Cancer
This is a pilot, randomized controlled trial of an embedded collaborative model of supportive care designed to improve quality of life and decrease use of unwanted healthcare services at the end of life for patients with advanced pancreatic cancer.
We will enroll 30 patients who are receiving treatment at the Hillman Cancer Center for recently diagnosed, locally advanced or metastatic pancreatic adenocarcinoma, as well as their accompanying caregivers and providers.
Patients will be randomized to receive either the supportive care intervention or usual care.
The purpose of this study is to refine an embedded collaborative model of supportive care and to develop protocols for recruitment, randomization, and longitudinal data collection.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
60
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15232
- University of Pittsburgh Cancer Institute (UPCI), Hillman Cancer Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
Patients:
- Adults (≥ 18 years old)
- Pathologically-confirmed locally advanced or metastatic pancreatic adenocarcinoma diagnosed within the past 8 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 (asymptomatic), 1 (symptomatic but fully ambulatory), or 2 (symptomatic and in bed <50% of the day)
- Planning to receive continued care from an oncologist at the Hillman Cancer Center
- Accompanied by a caregiver (family member or friend) at the first visit
Caregivers:
- Adults (>= 18 years old)
- Family member or friend of an eligible patient
Exclusion Criteria:
Patients:
- Unable to read and respond to questions in English
- Not planning to receive continued care from an oncologist at the Hillman Cancer Center
- Pancreatic neuroendocrine cancer
Caregivers:
- Unable to read and respond to questions in English
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Supportive Care Intervention
Monthly (minimum) patient & caregiver visits with a Supportive Care physician, embedded within their standard oncological care (through collaboration with oncology providers).
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Sem intervenção: Usual Care
Participants will receive standard oncology care from their oncology providers.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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trial feasibility
Prazo: up to 2 years
|
We will assess trial feasibility by monitoring number of eligible patients per clinic day, contact rates, interest rates, enrollment rates, randomization rates, intervention visit completion rates, and outcome assessment completion rates.
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up to 2 years
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acceptability of intervention participation
Prazo: 3 months (+/- 3 weeks) from patient enrollment
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We will report the percentage of patients and caregivers who found the intervention acceptable.
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3 months (+/- 3 weeks) from patient enrollment
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intervention fidelity
Prazo: Up to 2 years
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We will use post-visit checklists to characterize the number and types of recommended topics covered during each supportive care intervention visit.
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Up to 2 years
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perceived effectiveness
Prazo: 3 months (+/- 3 weeks) from patient enrollment
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We will report the percentage of patients and caregivers who perceived the intervention to be effective for treating symptoms, understanding their illness, coping, and planning for the future.
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3 months (+/- 3 weeks) from patient enrollment
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
change in patient quality of life
Prazo: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution of change in patient quality of life from baseline to 3 months using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep).
Because this is a pilot trial, we will not conduct formal tests of efficacy.
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baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
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patient healthcare utilization
Prazo: up to 2 years
|
We will summarize range and distribution of the following patient healthcare utilization outcomes: number and types of chemotherapy regimens, frequency and timing of chemotherapy regimens, number and length (days) of hospital admissions, number and length (days) of ICU admissions, number of emergency department visits, frequency and timing (days before death) of hospice use, place of death.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
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up to 2 years
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patient quality of life
Prazo: 3 months (+/- 3 weeks) from patient enrollment
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We will summarize range and distribution of patient quality of life at 3 months using the FACT-Hep scale.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
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3 months (+/- 3 weeks) from patient enrollment
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
patient illness understanding and care preferences
Prazo: 3 months (+/- 3 weeks) from patient enrollment
|
We will assess range and distribution of patient illness understanding using validated questions about patients' perceptions of curability, life expectancy, acknowledgement of whether or not s/he has a terminal illness, and preferences for comfort-oriented vs life-prolonging treatment.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
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3 months (+/- 3 weeks) from patient enrollment
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change in patient anxiety symptoms
Prazo: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will assess change in patient anxiety symptoms with the Hospital Anxiety and Depression Scale (HADS) administered at baseline and 3 months.
HADS scores will be compiled to assess range and distribution.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
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change in patient distress
Prazo: baseline (time of enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution of change in patient distress responses from baseline to 3 months, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool, where patients rate their distress on a visual guide from 0, 'no distress' to 10, 'extreme distress.'
Scores will be compiled to assess range and distribution at 3-months.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
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baseline (time of enrollment) to 3 months (+/- 3 weeks) after enrollment
|
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change in patient depressive symptoms
Prazo: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will assess change in patient depression from baseline to 3 months with the Hospital Anxiety and Depression Scale (HADS) and the Primary Care Evaluation of Mental Disorders: Patient Health Questionnaire (PRIME-MD PHQ-9).
HADS and PHQ-9 depression scores will be compiled to assess range and distribution at baseline and 3 months.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
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change in caregiver distress
Prazo: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution of change in caregiver distress responses from baseline to 3 months, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
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change in caregiver burden
Prazo: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will summarize the range and distribution of the reported change in caregiving burden from baseline to 3 months, collected with the Zarit Burden Interview and Family Member Concerns scale.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
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baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
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caregiver grief
Prazo: 1-3 months after death of enrolled patient
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We will assess caregiver grief after the death of their loved one (enrolled patient), if the patient dies during study participation and up to 2-year follow up.
We will use the Inventory of Complicated Grief to assess how much and how often caregivers are affected by the loss of their loved one and summarize the range and distribution of this data.
Because this is a pilot study, we will not conduct formal tests of efficacy.
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1-3 months after death of enrolled patient
|
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change in caregiver anxiety symptoms
Prazo: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will assess change in caregiver anxiety symptoms from baseline to 3 months with the Hospital Anxiety and Depression Scale (HADS).
HADS scores will be compiled to assess range and distribution.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
|
change in caregiver depressive symptoms
Prazo: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will assess change in caregiver depressive symptoms from baseline to 3 months with the Hospital Anxiety and Depression Scale (HADS).
HADS scores will be compiled to assess range and distribution.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
|
caregiver perceptions of circumstances surrounding death and preparedness for death
Prazo: 1-3 months after death of enrolled patient
|
We will assess caregiver perceptions of circumstances surrounding death and preparedness for death using four previously validated questions.
We will summarize range and distribution of responses.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
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1-3 months after death of enrolled patient
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quality of life of seriously ill patients
Prazo: 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution of patient quality of life using the Quality of Life - Seriously Ill Patients (QUAL-E) score.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
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3 months (+/- 3 weeks) after enrollment
|
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patient emotional acceptance of illness
Prazo: 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution of patient emotional acceptance of illness using the PEACE Scale.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
|
patient anxiety
Prazo: 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution of patient anxiety using the Hospital Anxiety and Depression Scale (HADS).
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
|
patient distress
Prazo: 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution in patient distress responses, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool, where patients rate their distress on a visual guide from 0, 'no distress' to 10, 'extreme distress.'
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
|
patient depression
Prazo: 3 months (+/- 3 weeks) after enrollment
|
We will assess patient depression from with the Hospital Anxiety and Depression Scale (HADS) and the Primary Care Evaluation of Mental Disorders: Patient Health Questionnaire (PRIME-MD PHQ-9).
HADS and PHQ-9 depression scores will be compiled to assess range and distribution.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
|
caregiver distress
Prazo: 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution in caregiver distress responses, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
|
caregiver burden
Prazo: 3 months (+/- 3 weeks) after enrollment
|
We will summarize the range and distribution of the reported caregiving burden, collected with the Zarit Burden Interview and Family Member Concerns scale.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
|
caregiver anxiety symptoms
Prazo: 3 months (+/- 3 weeks) after enrollment
|
We will assess caregiver anxiety symptoms with the Hospital Anxiety and Depression Scale (HADS).
HADS scores will be compiled to assess range and distribution.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
|
caregiver depressive symptoms
Prazo: 3 months (+/- 3 weeks) after enrollment
|
We will assess caregiver depressive symptoms with the Hospital Anxiety and Depression Scale (HADS).
HADS scores will be compiled to assess range and distribution.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Yael Schenker, MD, MAS, University of Pittsburgh
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de julho de 2013
Conclusão Primária (Real)
1 de agosto de 2015
Conclusão do estudo (Real)
1 de agosto de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
7 de junho de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de junho de 2013
Primeira postagem (Estimativa)
25 de junho de 2013
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
12 de maio de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de maio de 2016
Última verificação
1 de maio de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PRO13020507
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